RecruitingNot ApplicableNCT05951101

Zenith LAA Occlusion System

Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)


Sponsor

AuriGen Medical Ltd

Enrollment

10 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique. Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a device called the Zenith LAA Occlusion System, which is a small implant inserted into the left atrial appendage (a small pouch in the heart) to reduce stroke risk in people with non-valvular atrial fibrillation (an irregular heartbeat). This procedure offers an alternative to long-term blood thinner medications. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of atrial fibrillation not caused by a heart valve problem - Your doctor has determined that you need the left atrial appendage to be sealed - You are willing to attend follow-up visits as required **You may NOT be eligible if...** - You have had a heart attack, stroke, or TIA in the past 90 days - You have severe heart failure symptoms (Class III or IV) - You have a bleeding disorder or very low platelets - You have severe kidney disease or are on dialysis - You need long-term blood thinners for a condition other than atrial fibrillation - You have an active infection or active pericarditis - You are pregnant or planning to become pregnant within 12 months - You have a BMI over 40 or a life expectancy of less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZenith LAA Occlusion System

LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm


Locations(3)

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Auckland City Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

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NCT05951101


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